A hernia often occurs in a muscle wall of an individual where the muscles have weakened, or where a previous surgical incision was made. Weakened abdominal muscles can result in a ventral hernia, which may produce a bulge or a tear forming in the surrounding tissue. The inner lining of the abdomen, the intestine, or other tissue can then push through the weakened area of the abdominal wall to form a hernia sack or bulge. Where a surgical incision was previously made in the abdomen, portions of the abdominal wall that have been sutured together can separate or tear between sutures over time. This also can result in the inner lining of the abdomen or other tissue pushing through the tear of the abdominal wall to form a bulge or hernia sack.
In large ventral hernias, the defect in the fascial tissue can be about 10 cm wide or greater. The defect may also lie under substantial layers of tissue. Of these layers, the skin is the outermost layer. Beneath the skin is subcutaneous fat, which may be about 5-10 cm or greater. An external fascial layer and a layer of rectus muscle lie beneath the fat, followed by the internal fascia, which is the layer to be closed. In large ventral hernia repair, it may be desirable for the suture to pass through three layers of the abdominal wall—the anterior rectus sheath, the rectus muscle, and the posterior rectus sheath—in order to incorporate all three layers of the abdominal wall into the suture closure.
Tens of thousands of ventral hernia repairs are performed in the United States each year. The conventional surgical repair procedure, or “open” method, requires that a large incision be made in the abdomen of the patient exposing the area of the hernia. The area of the hernia can be reinforced by a surgical mesh and/or closed by sutures. Since a large incision is usually made in the abdomen, the open method of repair can result in increased post-operative pain, an extended hospital stay, a restrictive diet, and an increased risk of surgical complications or infection.
To alleviate some of these issues, laparoscopic procedures have also been developed for repairing ventral hernias. These minimally invasive procedures repair the hernia opening in the abdominal wall using small incisions in the abdomen. Laparoscopes and surgical mesh are typically used in these procedures. In particular, a mesh may be inserted through a trocar and positioned at the surgical site in the abdomen to reinforce the abdominal wall in the area of the hernia. The laparoscopic method of repair can result in decreased post-operative pain and a shorter hospital stay. However, the laparoscopic procedure can also produce some adverse affects. For example, the positioning of the surgical mesh in the abdomen can result in the mesh irritating the intestines or other abdominal contents. In addition, the surgical mesh can move in the abdomen from its original position, exposing the hernia site and creating the potential for the development of another ventral hernia.
Methods of closing the hernia using a suture, however, typically are not performed in laparoscopic ventral hernia repair for a variety of reasons. In particular, laparoscopic suturing may be difficult to perform since manipulation of the needle takes place in a confined space, typically under the skin, where the angle of tissue access for suture placement is often determined by trocar port site selection. Additionally, since fascial openings may be large, it may be difficult or impossible to thread a suture through opposing sides of the fascia using a needle and/or traditional laparoscopic equipment when working via laparoscopic incisions or needle punctures. Furthermore, substantial tension is required to bring the edges of the fascia together in large ventral hernias. It may also be difficult or impossible to apply a large amount of tension to suture and tie knots in the suture using traditional laparoscopic instrumentation.
In some laparoscopic hernia repair, a surgeon can use a technique where a suture passer is inserted through a midline incision in order to grasp suture ends at the edge of the fascial opening, and pull them out through the midline incision for subsequent tying. However, if the hernia is large or the patient is obese, using a suture passer in this way may be difficult or impossible because the edges of the fascial opening may be relatively distant from the midline and/or the suture may have to pass through multiple layers of tissue for closure. Since suture passers are typically rigid, the angle at which the suture passer is inserted in order to reach from the midline to the edge of the opening in a large hernia may be severe, making it difficult or substantially impossible to grasp the suture end and subsequently draw it out of the midline incision. It may be desirable, instead, for a device that can grasp the suture to be inserted at an angle substantially perpendicular to the skin.
Another technique for repairing a ventral hernia using a suture is known as the Components Separation (“CS”) Method. The CS method attempts to reduce hernia recurrence by reducing tension caused by sewing the defect closed. Using this method, a surgeon typically creates a large, open incision in the abdomen, then bluntly dissects the external and internal oblique muscles from the overlying skin, the underlying posterior rectus sheath, and from each other. The surgeon can then shift the layers of tissue so the fascial opening is moved toward the abdominal midline. Shifting the defect prior to sewing the defect closed can reduce tension on the defect and any suture used to close the defect.
Accordingly, it would be desirable to have an effective fascial closure system that can deliver sutures to the site of a fascial opening through laparoscopic incisions or punctures in order to close the opening, while minimizing or reducing the likelihood of tearing.